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Boston Scientific Corporation Message Board

  • bsxxx2000 bsxxx2000 Oct 18, 2000 9:43 AM Flag


    I heard there is a hospital in New Jersey that resterilizes and re-uses our balloons! Is this true? Is this good for the balloon? Patient? Profits?

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    • Clinic:
      Would you please read the class the first sentance of message 11585. We'll wait...


      You can apologize later, as I know you will...

    • Without sounding like Clinton, if you call them,
      they are quite washy on the subject. You are correct,
      I was however referring to the "real" stance they
      are taking visa vie the bottom line that seems to be
      of discussion; that is should it be allowed at all,
      regardless of where the liability dart may end up sticking.
      As you know, legality and liability are often two
      entirely different matters, and when the subject of "right
      vs. wrong" is put into play, well that's a three
      headed monster.

    • If they've had surgery in the past 5 years, it's already happened. As for the condoms, your're the captain of your own ship...

    • heart-
      Thanks for the clarification. You're
      right, it was me. And I stand by it. The string of posts
      on this topic are nonsense and way off from the
      original message. I never said I would WANT one of these
      devices used on me . . . bottom line is that it still
      happens. FDA guidelines or not.
      I believe you agreed
      with me.


    • LOLROTF!!!!!! C'mon Beez you gotta give as good as you got.

    • beez will like this article. Part 2

      that regulatory burden has FDA worried, too. The
      agency has already expressed concerns that the task of
      regulating reprocessed devices will make it harder to
      approve new devices in a timely manner. A huge influx of
      510(k)s could conceivably generate the sort of backlog
      that made FDA so notorious in the past. In an effort
      to shift or share the burden, FDA has reportedly
      asked HCFA and the Joint Commission on Accreditation of
      Healthcare Organizations to include SUD reprocessing in
      their hospital quality-of-care standards. So far,
      neither organization has agreed to do so.

      reprocessing industry has long protested that FDA regulation
      would essentially put them out of business, but the GAO
      report suggests a very different outcome. "At least some
      third-party firms anticipate an increase in business," the
      report says, "both because of the expected shift in
      reprocessing from hospitals and because they expect that FDA's
      formal approval of the reprocessing of particular SUDs
      will improve their marketing success." Is it possible
      that device reprocessors will be the real winners in
      the regulatory feud? That's certainly not the
      scenario envisioned by AAMI, AdvaMed, MDMA, and others�but
      one that could well play out in the next year or
      two.�Gabriel Spera

    • beez will like this article. Part 1

      Looks Favorably on Device Reprocessing
      August 22,

      A recent study by the Government Accounting Office
      (GAO) found little evidence to support the widespread
      belief that reprocessed single-use devices (SUDs) pose a
      significant health risk.

      The study, commissioned by
      Congress, comes less than a month after the release of
      FDA's final guidance on device reprocessing, which
      codifies FDA's regulation of reprocessors and sets a
      timetable for enforcement based on the risk classification
      of the devices involved. Under the revised
      framework, independent reprocessing firms and hospitals will
      have to obtain FDA approval before they can reprocess
      devices labeled for single use.

      Not surprisingly,
      GAO could find no hard figures on the extent of SUD
      reprocessing or even get a solid account of the types of
      devices most often reprocessed. Still, the agency cites
      estimates that 20�30% of US hospitals routinely reprocess
      some devices, and of those, about a third get these
      items through independent reprocessors. For its part,
      FDA has identified only 13 third-party reprocessors,
      although it suspects more are in operation.

      conceding certain "theoretical health risks" posed by
      reprocessed SUDs, the GAO report makes reference to clinical
      evidence showing that certain devices can be reprocessed
      safely. Indeed, the report states that "some
      infection-control experts told GAO that the careful reprocessing of
      appropriate SUDs has not been demonstrated to be a public
      health risk."

      Industry representatives and
      patient advocates would certainly disagree. Some have
      argued that hospital infections are difficult to trace
      back to a particular device, while others have
      suggested that healthcare providers would be loathe to
      admit that an adverse incident was caused by
      reprocessed device that was only being used to save money. To
      be fair, the GAO report concedes that "current
      surveillance systems almost certainly do not detect all
      infections and injuries resulting from the use of
      reprocessed SUDs," and that certain devices types or
      particular models can not be reprocessed safely.

      Interestingly, although hospitals have traditionally sought to
      downplay the economics of SUD reprocessing, the GAO report
      gives unabashed attention to these financial
      considerations. The report plainly states that "substantial cost
      savings can be achieved by reprocessing SUDs" and notes
      that SUDs obtained through a third-party reprocessor
      usually cost half as much as a brand-new device; devices
      reprocessed in-house can cost less than a tenth of the price
      of a new device. In addition, a trade association
      representing major third-party reprocessors said its members
      raked in about $20 million for their services last
      year. With figures like these, it's no wonder that SUD
      reprocessing has become such a major concern. Alarmingly, GAO
      believes that "the competition created by SUD reprocessing
      appears to have caused some original device manufacturers
      to reduce their prices to certain purchasers."

      Of course, as reprocessors (particularly hospitals)
      are forced to shoulder a greater regulatory burden,
      those cost savings could easily decrease to the point
      where they no longer justify the higher risk and
      liability. In a sense, that's what reprocessing opponents
      have been hoping all along.

    • Wrong again beez, the author of "Let's be realistic" was cath_man_2000 msg. 11561.

      Thanks beez, I enjoyed it also.

    • Beez,

      Not sure how you missed it but here is the FDA guidance document on

      The �Enforcement Priorities for Single-Use Devices Reprocessed by Third Parties and
      Hospitals� document provides guidance to third party and hospital reprocessors about
      responsibility as manufacturers engaged in reprocessing devices labeled for single
      use under the
      Federal Food, Drug, and Cosmetic Act (the Act), as amended by the Safe
      Medical Devices Act
      of 1990, the Medical Device Amendments of 1992, and the Food
      and Drug Modernization
      Act of 1997. Third party and hospital reprocessors of single-use
      devices are subject to
      all the regulatory requirements currently applicable to original
      manufacturers, including premarket submission requirements (Sections 513
      and 515 of the Act; 21
      Code of Federal Regulations Parts 807 and

      Can we put this one to bed now?

    • their lead and save a few bucks by washing out
      our rubbers and reusing those a few times too
      especially with interchangable partners, YAHOOO!

      no way would I want a reconditioned one time use
      device used on me or a loved one and this practice
      should be stopped.

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